0371-Brand Name-Johnson redacted.pdf

VHAPG Part 813.5 Simplified Acquisition Procedures for Certain Commercial Items Attachment 1: Request for Brand Name Justification Template >SAT-$7.5M under FAR13.5

Effective Date: 02/01/2022 Page 1 of 5

DEPARTMENT OF VETERANS AFFAIRS

Brand Name JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL

ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 36C250-22-AP-5087 Estimated Total Value:

1. Contracting Activity: Department of Veterans Affairs, VISN 10

Lt. Charles S. Kettles VA Medical Center

2215 Fuller Rd

Ann Arbor, MI 48105

2237: 506-22-3-118-0371

2. Nature and/or Description of the Action Being Processed:

This is a Brand Name only procurement for the EYESI surgical simulator. This is a surgical simulator for trainees that simulates the various steps of both cataract and retina surgery. These are the 2 procedures the VA does most. The simulator enables residents to practice the various steps of surgery to improve their skill and efficiency without risk to patients.

This procurement will be in accordance with FAR 13.5 Simplified Procedures for Certain Commercial Items and specifically FAR 13.501 Special Documentation Requirements, where acquisitions conducted under Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6, but still require a justification using the format of FAR 6.303-2. The action will be awarded as a new firm-fixed price contract.

3. Description of Supplies/Services Required to Meet the Agency’s Needs:

Estimated delivery date: 45 Days ARO

ITEM INFORMATION

ITEM

NUMBER

DESCRIPTION OF

SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

0001 1.00 EA

EYESI SURGICAL COMPLETE SYSTEM TO INCLUDE THE FOLLOWING

PART#'S: PS-2004_W - SURGICAL PLATFORM 2.11 SOFTWARE -

SIMULATOR SOFTWARE SI-C_2011 CAT SURGERY INTERFACE PACK IS-C003

- INCLUDING CAT HAND -ACTIVATED FORCEPS TMP-C001- EYESI CAT BASIC

SKILLS PACK 1(LICENCE) INCLUDING: ANTI TREMOR TRAINING, FORCEPS

TRAINING, PHACO BASIC SKILLS TRAINING. TMP-C002 -EYESI CAT BASIC

SKILLS PACK 2 (LICENCE) INCLUDING: NAVIGATION TRAINING, BIMANUAL

TRAINING, CHOPPING & CRACKING TRAINING. TMP-C003- EYESI CAT

Effective Date: 02/01/2022 Page 2 of 5

BASIC SKILLS PACK 3 (LICENCE)INCLUDING: INTRACAPSULAR ANTI-

TREMOR, INTRACAPSULAR NAVIGATION TRAINING, PHACO CHOPPING

TRAINING, CAPSULOHEXIS(LICENCE), HYDROMANEUVERS (LICENCE),

PHACO DIVIDE & CONQUER (LICENCE), IRRIGATION ASPIRATION (LICENCE),

IOL INSERTION (LICENCE), IOL INSERTION (LICENCE)ANTERIOR

VITRECTOMY (LICENCE), IRIS EXPANSION RING (LICENCE), CAPSULAR

TENSION RING (LICENCE) SI-V_2011- VIT SURGERY INTERFACE PACK IS-

VOO2 - VIT HAND-ACTIVATED FORCEPS SI-AO02 - VIT BIOMv5/SDI MIMIC

TMP-V101 - VIT BASIC SKILLS PACK (LICENCE) INCLUDING: VIT FROCEPS

TRAINING, VIT ANTI TREMOR TRAINING, VIT VITRECTOR TRAINING, TMP-

V102 - VIT BASICSKILLS PACK (LICENCE) INCLUDING: NAVIGTION TRAINING,

VIT BIMANUAL TRAINING, BIMANUAL SCISSORS TRIANING. TM-V101 - VIT

EPIRETINAL MEMBRANCES (LICENCE) TM-V102 - VIT ILM PEELING

(LICENCE) TM-V103 - VIT POSTERIOR HYALOID (LICENCE) TM-V104 - VIT

ENDOLASER (LICENCE) TM-V105 - VIT RETINAL DETACHMENT (LICENCE)

CW_C1 - CAT TRAINING COURSEWARE (LICENCE) CW_v1 - VIT TRAINGING

COURSEWARE (LICENCE) SKILLS PACK 2 (LICENCE)

LOCAL STOCK NUMBER: COMPLETE SYSTEM

Funding/Req. Number: 1 506-22-3-118-0371

0002 1.00 EA

EYESI SURGICA COMPLETE GOLD SOFTWARE PLAN 36M INCLUDING

ACCESS TO VRmNET DURIGN VALIDITY PERIOD.

LOCAL STOCK NUMBER: COMPL-003_36

Funding/Req. Number: 1 506-22-3-118-0371

0003 1.00 EA EYESI

SURGICAL CAT HAND-ACTIVATED FROCEPS (SPARE INST SET)

ESMP_IN_CAT_A_S - ES CAT ANGLED INSTUREMENT ESMP_IN_CAT_P_S -

ES CAT PHACO ANGLED INSTURMENT

LOCAL STOCK NUMBER: CAT SPARE INSTURMENT SET

Funding/Req. Number: 1 506-22-3-118-0371

GRAND TOTAL

4. Statutory Authority Permitting Restricted Competition:

FAR 13.5 Simplified Procedures for Certain Commercial Items. The statutory authority for applying the Simplified Procedures for Commercial Items of FAR 13.5 is 41 U.S.C. § 1901 and is implemented by FAR 13.106-1(b)(2) for restricting competition on this procurement. Competition is restricted on this procurement for the reason below:

Effective Date: 02/01/2022 Page 3 of 5

(x ) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency

Requirements – Brand Name

( ) Unusual and Compelling Urgency

( ) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert

Services

( ) International Agreement

( ) Authorized or Required by Statute

( ) National Security

( ) Public Interest

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition

Requires the Use of the Authority Cited Above (applicability of authority):

Brand Name only

The Ophthalmology Section of the Surgical Service at the Lt. Charles S. Kettles VA Medical Center is requesting one (1) EYESI Surgical Simulator to replace the current end-of-life system. The staff is currently trained on simulations that are proprietary to the EYESI simulator only. Additionally, system includes unique features such as Quad camera optical tracking system, dedicated patient interface

(head) for cataract surgery, dedicated patient interface (head) for retina surgery, BIOM 2 retina viewing system adapted for virtual surgery, hand activated forceps for cataract surgery and hand activated forceps for retina surgery. No patient data will be transferred, as the EYESI Surgical

Simulator is a freestanding PC based training platform. It is not networked and contains no patient information which ensures patient data safety. Trainees receive immediate feedback on performance after each simulation task, so they are able to adjust techniques that aid trainees in reaching surgical competency sooner and with fewer complications.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable:

Brand name only procurement. Contacted Haag-Streit to see if they had any authorized distributors.

The sales representative advised they have 1 SDVOSB distributor, Corps Medical. The requested items do not appear on the NMR waiver list. A sources sought was posted to sam.gov and there were 0 responses. The VA Rule of Two is unattainable for this procurement. An open market, brand name, unrestricted solicitation will be posted to sam.gov.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable:

The brand name acquisition will be awarded to the lowest price of all quotes received. To determine price reasonableness, the quote will be compared to the IGCE, and the market research quote provided by the end-user.

Effective Date: 02/01/2022 Page 4 of 5

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons

Market Research Was Not Conducted:

Searched VetBiz using NAICS code 339115 and keywords Surgical Simulator. Located 29 SD/VOSB vendors. I also searched GSA and VANAC, and there were 0 vendors Located. A search of SBA.gov also resulted in 0 vendors being located. I contacted the OEM and was advised they have 1 distributor for this product. The VA Rule of Two is not attainable for this procurement.

Items can be procured open market through two different sources, the OEM (large business) and its SDVSOB distributor. Confirmed both vendors have active SAM accounts. Corps Medical Supply, LLC is listed on vetbiz.gov as a SDVOSB. Past performance is good for both vendors (green in the CRA). Recommend open market, unrestricted, brand name procurement using FAR 13.5.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition:

None

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition:

Haag-Streit

Corps Medical

11. A Statement of the Actions, if any, the Agency May Take to Remove or Overcome any Barriers to

Competition before Making subsequent acquisitions for the supplies or services required:

Should another requisition of this nature occur, market research will be conducted to identify comparable and competitive products in the commercial marketplace.

12. Requirements Certification: I certify that the requirement outlined in this justification is a Bona Fide

Need of the Department of Veterans Affairs and that the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge and belief.

Digitally signed by BARBARA J.

MONTALVO 286112

MONTALVO 286112 Date: 2022.08.03 15:46:48 -04'00'

Barbara Montalvo

Administrative Officer

Lt. Charles S. Kettles VA Medical Center

13. Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:

BARBARA J.

Effective Date: 02/01/2022 Page 5 of 5

a. Contracting Officer or Designee’s Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Percy Johnson

Contracting Specialist

Network Contracting Office 10

Kellie Konopinski

Contracting Officer

Network Contracting Office 10

b. One Level Above the Contracting Officer (Required over SAT but not exceeding $750K): I certify the justification meets requirements for other than full and open competition.

Digitally signed by ADAM WEBER

Date: 2022.08.08 15:13:42 -04'00'

Adam Weber Branch Chief

Supply Team #1 Ohio

Network Contracting Officer for

Diana J Pittman

Branch Chief, Supply Team 3

Network Contracting Office

PERCY

JOHNSON

Digitally signed by PERCY

JOHNSON

Date: 2022.07.29 09:18:30

-04'00'

Digitally signed by Kellie

Kellie J. Konopinski J. Konopinski 480975

480975 Date: 2022.08.08

12:59:11 -04'00'

ADAM WEBER